A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors (NCT04857372) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors
United States137 participantsStarted 2021-10-21
Plain-language summary
The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study.
✓. Male or female patients must be ≥ 18 years of age.
✓. Dose escalation part: patients with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma or other solid tumors. Patients with solid tumors other than mesothelioma must have local available data for loss-of-function NF2/LATS1/LATS2 genetic alterations (truncating mutation or gene deletion; LATS1/LATS2 mutations will only be included in the dose escalation part), or functional YAP/TAZ fusions. Patients with malignant EHE can be enrolled with only histological confirmation of the disease. Patients must have failed available standard therapies, be intolerant of or ineligible for standard therapy, or for whom no standard therapy exists.
✓. Dose expansion part: the following patients will be enrolled into 3 different treatment groups:
✓. Presence of at least one measurable lesion according to mRECIST v1.1 for mesothelioma patients, RECIST v1.1 for patients with other solid tumors, or RANO for patients with primary brain tumors.
✓. Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/baseline, and again during therapy on this study. An archival tumor sample may be used at screening. During the dose expansion part of the study, a decision may be made to stop the collection of on-treatment biopsies.
Exclusion criteria
✕. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
What they're measuring
1
Number of patients with adverse events and serious adverse events
Timeframe: 3 years
2
Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only)
Timeframe: 1 year
3
Number of patients with dose interruptions and dose changes
. ≤ 4 weeks for thoracic radiotherapy to lung fields or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment. An exception to this exists for patients who have received palliative radiotherapy to bone, who must have recovered from radiotherapy-related toxicities but for whom a 2-week washout period is not required.
✕. ≤ 4 weeks or ≤ 5 half-lives (whichever is shorter) for biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
✕. ≤3 weeks for treatment with cytotoxic agents or ≤ 6 weeks for cytotoxic agents with risk of major delayed toxicities, such as nitrosoureas and mitomycin C.
✕. ≤ 4 weeks for immuno-oncologic therapy, such as CTLA4, PD-1, or PD-L1 antagonists
✕. Prior treatment with TEAD inhibitor at any time
✕. For mesothelioma patients: use of non-invasive antineoplastic therapy (e.g., tumor treating fields, brand name Optune LuaTM) within 2 weeks of the tumor assessment at screening.
✕. Malignant disease, other than that being treated in this study.